Soothing Pain Relief

Soothing Pain Relief
SPL v1
SPL
SPL Set ID f237a74d-5c5d-4c32-a7f4-af4484988c7c
Route
TOPICAL
Published
Effective Date 2019-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (2 mg)
Inactive Ingredients
Camphor (synthetic) Water Eucalyptus Oil

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-03-04

Description

Drug Facts

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.
Section 50567-7
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
Section 50570-1
  • Avoid contact with the eyes.
Warnings
  • For external use only.
Directions
  • Adults and children 2 years of age and older:

    apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, consult a Physician.
Indications

for the temporary relief of minor aches and pains of muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Active Ingredients

Menthol 2%

Inactive Ingredients

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

Principal Display Panel 59.1 Ml Bottle Label

Soothing

Pain Relief

Roll-On

2 Fl Oz (59.1 ml)

Rejuvenetics™


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a Physician.
Section 50567-7 (50567-7)
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
Section 50570-1 (50570-1)
  • Avoid contact with the eyes.
Purpose

Topical analgesic

Warnings
  • For external use only.
Directions
  • Adults and children 2 years of age and older:

    apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age, consult a Physician.
Indications

for the temporary relief of minor aches and pains of muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Active Ingredients

Menthol 2%

Inactive Ingredients (Inactive ingredients)

Water, Butylene Glycol, Aloe Barbadensis Leaf Juice, Eucalyptus Globulus Leaf Oil, Methyl Salicylate, Camphor, Mentha Piperita (Peppermint) Oil, Silica, Potassium Citrate, Magnesium Carbonate, Oleic Acid, Carbomer, Triethanolamine, Propylparaben, Methylparaben, Diazolidinyl Urea, Tetrasodium EDTA.

Principal Display Panel 59.1 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label)

Soothing

Pain Relief

Roll-On

2 Fl Oz (59.1 ml)

Rejuvenetics™


Advanced Ingredient Data


Raw Label Data

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